- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319312
Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania
December 21, 2025 updated by: Nyagwaswa Athanas Michael, Shandong University
Evaluating the Clinical Effectiveness and Implementation Outcomes of Nurse-Led Stroke Transitional Care Model in Tanzania
The goal of this observational study is to assess the effects of nurse-led stroke transitional care in stroke survivors, caregivers and healthcare providers who participate in nurse-led stroke transitional care program to improve discharge preparedness, disease self-management and quality of life among stroke survivors.
The main question it aims to answer is: does nurse-led stroke transitional care program improve discharge preparedness, disease self-management and quality of life among stroke survivors?
Participants are currently participating in nurse-led stroke transitional care program as part of their medical care.
Stroke survivors and their caregivers will be followed for six months period to assess their transitional care quality and clinical outcome measures.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nyagwaswa Michael, Masters
- Phone Number: +255685005923
- Email: nyagwaswamichael04@gmail.com
Study Locations
-
-
-
Dar es Salaam, Tanzania, 65001
- Recruiting
- Muhimbili University of Health and Allied Sciences
-
Contact:
- Nyagwaswa Michael, Masters
- Phone Number: +255685005923
- Email: nyagwaswamichael04@gmail.com
-
Contact:
- Lilian Mselle, PhD
- Phone Number: +255717565610
- Email: nakutz03@gmail.com
-
Principal Investigator:
- Nyagwaswa Michael, masters
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study will include nurses, doctors, stroke survivors and caregivers who are directly involved in hospital-to-home transition.
Description
Inclusion criteria
- Clinical nurses and physicians with six months of working experience in stroke care
- Clinical nurses and physicians with a minimum of diploma in their professions.
- Stroke survivors with 18 years old and above
- Stroke survivors admitted in the stroke units
- Stroke survivors with primary diagnosis of stroke confirmed by brain CT/MRI
- Stroke survivors who undergo usual discharge process
- Stroke survivors who live with their family caregivers
- Stroke survivors who have mobile phones
- Stroke survivors who can read and write
- Stroke survivors who are able to communicate
- Stroke survivors with National Institutes of Health Stroke Scale (NIHSS) < 6
- Stroke survivors with Modified Barthel Index (MBI) > 9
- Stroke survivors with Modified Rankin Scale (mRS) < 5
- Stroke survivors with Montreal Cognitive Assessment Test (MoCA) > 14
- Stroke survivors who are expected to stay in the ward for 3-5 days,
- Stroke survivors who are expected to survive for 3 months
- Family caregivers with mobile phones
- Family caregivers who can read and write
- Family caregivers who are able to communicate
- Family caregivers who live with the patient after stroke
Exclusion criteria
- Healthcare providers who will be on leave during the study period.
- Stroke survivors with previous stroke who are not admitted in stroke units
- Stroke survivors who are discharged against medical advice
- Stroke survivors who have end-stage organ failure
- Stroke survivors who have family caregivers
- Stroke survivors who can't read/write
- Stroke survivors who have no mobile phones.
- Family caregivers without mobile phone that is accessible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Historical control group
Stroke survivors and their caregivers received usual care
|
Participants in intervention group will receive usual care plus nurse-led stroke transitional care.
Two nurse champions will conduct the face-to-face sessions while other two nurse researchers will conduct the telephone call sessions between August and December, 2025.
During hospitalization, the two nurse champions will conduct five face-to-face sessions (2 individual sessions at admission; and at discharge), and three group sessions with 2-4 dyads of patients and caregivers.
After hospitalization, two nurse researchers will conduct seven follow-up sessions for three months via phone calls at day 3, week 1, week 3, week 5, week 7, week 9, and week 11.
The face-to-face sessions and phone call sessions will take 40-60 minutes and 20-30 minutes respectively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy among stroke survivors
Time Frame: 6 months after discharge
|
Ability to take control and perform recommended health behaviors and discharge instructions.
Self-efficacy will be measured by the Stroke Self-Efficacy Questionnaire (a=0.9)
developed by Jones and colleagues.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate better ability to follow and adhere to healthy lifestyles after stroke
|
6 months after discharge
|
|
Quality of life among stroke survivors
Time Frame: 6 months after discharge
|
Quality of life that will be measured by the Stroke Specific Quality of Life (SSQoL) with (a=0.85).
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate better quality of life as evidenced by ability to perform self-care activities, improved cognitive function, mobility, and engaging in social activities
|
6 months after discharge
|
|
Discharge preparedness among survivors
Time Frame: within 1 month after discharge
|
Discharge preparedness that will be measured by the Short Forms of the Readiness for Hospital Discharge Scale (RHDS) developed by Weiss.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate readiness for hospital-to-home discharge among stroke survivors.
|
within 1 month after discharge
|
|
Discharge preparedness among health care providers
Time Frame: within 1 month after discharge
|
Discharge preparedness that will be measured by the Short Forms of the Readiness for Hospital Discharge Scale (RHDS) developed by Weiss.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate agreement on readiness for hospital-to-home discharge among nurses and doctors.
|
within 1 month after discharge
|
|
Resilience among caregivers
Time Frame: 6 months after discharge
|
Resilience will be measured by the 10-items Connor-Davidson Resilience Scale (CD-RISC) validated by Laura with a=0.85).
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate better ability and readiness to take care giving responsibilities.
|
6 months after discharge
|
|
Quality of transition care among survivors and caregivers
Time Frame: within 1 month after discharge
|
Quality of TC will be measured by the Care Transitions Measure (CTM) Tool developed by Eric Coleman.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate better perceived quality of transition care.
|
within 1 month after discharge
|
|
Caregiver self-efficacy
Time Frame: 6 months after discharge
|
Caregiver self-efficacy will be measured by the 10-items Family Caregiver Activation Tool (FCAT) developed by Coleman with a=0.6.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate better ability to assist the stroke survivors to follow and adhere to healthy lifestyles and clinic appointment after stroke
|
6 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression and anxiety among survivors and caregivers
Time Frame: 6 months after discharge
|
Depression and anxiety that will be measured by the locally validated 10-items Kessler Psychological Distress Scale with a=0.85.
This will be measured by a scale as total scores and mean scores.
High total and mean scores indicate poor mental health status after discharge.
|
6 months after discharge
|
|
Care satisfaction among survivors and caregivers
Time Frame: within 1 month after discharge
|
Satisfaction of hospital care will be measured by a questionnaire developed specific for this study.
It will be measured as total scores and mean scores.
High total and mean scores indicate good satisfaction with transitional care.
|
within 1 month after discharge
|
|
Mortality among survivors
Time Frame: 6 months after discharge
|
This will be counted as a death event after discharge.
|
6 months after discharge
|
|
readmission among survivors
Time Frame: 6 months after discharge
|
This will be measured as number of times the patient is readmitted at the hospital after discharge.
High frequency will indicate many readmissions.
|
6 months after discharge
|
|
length of hospital stay among survivors
Time Frame: Day 1 after discharge
|
This will be measured as number of days spent in the hospital before discharge.
This will be calculated as number of days spent at the hospital from admission to discharge.
High number above 5 indicates long hospital stay.
|
Day 1 after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Estimated)
March 25, 2026
Study Completion (Estimated)
March 30, 2026
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
December 21, 2025
First Posted (Actual)
January 6, 2026
Study Record Updates
Last Update Posted (Actual)
January 6, 2026
Last Update Submitted That Met QC Criteria
December 21, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Shandong@2025
- 72274110 (Other Grant/Funding Number: National Natural Science Foundation of China)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I will consider sharing it upon finishing enrollment of participants
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke Acute
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
-
Capital Medical UniversityCompletedAcute Ischaemic Stroke | Stroke-associated PneumoniaChina
-
University of CalgaryThe George Institute for Global Health, AustraliaRecruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Chinese University of Hong KongThe Hong Kong Polytechnic University; City University of Hong Kong; Hong Kong... and other collaboratorsRecruitingAcute Ischemic Stroke | Acute Stroke | Acute Stroke InterventionHong Kong
-
Prof. Dr. Jan LimanUniversity Hospital, Basel, Switzerland; Klinikum Nürnberg; Deutsche ForschungegemeinschaftRecruitingHemorrhagic Stroke, Intracerebral | Acute Ischemic Stroke AIS | Stroke AcuteSwitzerland, Germany
-
University of MiamiNo longer availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Hospital Universitari Vall d'Hebron Research InstituteMethinks Software SLRecruitingStroke | Ischemic Stroke, Acute | Thrombectomy | Stroke AcuteSpain
-
NeurotechnikaSamara State Medical University; Samara Regional Clinical Hospital V.D. SeredavinRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Acute | Stroke, Acute, Ischemic | Stroke with HemiparesisRussian Federation
-
Southwest Hospital, ChinaRecruitingAcute Ischemic Stroke PatientsChina
Clinical Trials on Nurse-led stroke transitional care program
-
The Hong Kong Polytechnic UniversityCompleted
-
University Hospital, BrestRecruitingLong Term Corticosteroid TherapyFrance
-
Sepulveda Research CorporationNational Institute of Neurological Disorders and Stroke (NINDS)CompletedIschemic Stroke | Transient Ischemic AttackUnited States
-
Taipei Medical UniversityNot yet recruitingCardiovascular Kidney Metabolic SyndromeTaiwan
-
McMaster UniversityHamilton Health Sciences Corporation; Ontario Ministry of Health and Long Term... and other collaboratorsCompleted
-
Radboud University Medical CenterCompleted
-
Istanbul University - Cerrahpasa (IUC)Istinye University Liv Hospital-Bahcesehir, Stroke CenterRecruiting
-
Marmara UniversityMarmara University, Scientific Research Projects CommitteeActive, not recruitingSchool Health | School Bullying | School Based Intervention | Bullying VictimizationTurkey (Türkiye)
-
University of MisanCompletedEnd-Stage Renal Disease; HemodialysisIraq
-
Central Hospital, Nancy, FranceActive, not recruiting